Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Location status: Recruiting
NCT Number: NCT07749989
This retrospective, observational cohort study aimed to establish a comprehensive research cohort utilizing a large-scale prospective clinical registry. The primary objectives were to characterize the real-world demographic profiles, clinical features, psychological characteristics, and treatment patterns of Chinese patients with gastroesophageal reflux disease (GERD), as well as to evaluate post-treatment improvements in both GERD symptoms and psychological well-being. The study retrospectively enrolled approximately 5,000 patients with a confirmed diagnosis of GERD, with data derived from the prospective registry of the National Clinical Research Center for Digestive Diseases. Investigators systematically extracted data on baseline demographics, clinical presentations, objective diagnostic findings, preoperative psychological status, surgical complications, and longitudinal follow-up outcomes for all eligible patients. Ultimately, this study sought to provide high-quality, China-specific evidence to inform the precise phenotyping of GERD and to guide standardized, individualized clinical decision-making.
Interested in participating?
Request Info18 year–90 year
All sexes
Observational
Beijing, Beijing Municipality, 100050, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Data on clinical symptoms, treatment details, and long-term follow-up outcomes were retrospectively extracted from electronic medical records (EMRs) and institutional databases.
Time frame: From pre-treatment to up to 10 years post-treatment
The Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) questionnaire is utilized to assess patient outcomes as a quantitative variable. The scale comprises 11 items, each scored from 0 to 5, with higher scores indicating a better quality of life (QoL). Clinical success is defined as a >50% reduction in the total symptom score.
Time frame: From pre-treatment to up to 10 years post-treatment
The Gastroesophageal Reflux Disease Questionnaire (GERD-Q) is utilized to evaluate GERD symptoms. The total score ranges from 0 to 18, with higher scores indicating greater symptom severity.
Time frame: From pre-treatment to up to 10 years post-treatment
The GERD Symptom Assessment Scale (GSAS) is employed to evaluate GERD symptoms. The total score ranges from 0 to 45, with higher scores indicating greater symptom severity.
Time frame: From pre-treatment to up to 10 years post-treatment
The Gastrointestinal Quality of Life Index (GIQLI) is utilized to assess quality of life in patients with gastrointestinal diseases. It comprises five subscales with a total score ranging from 0 to 144. Higher scores indicate a better quality of life and superior therapeutic efficacy.
Time frame: From pre-treatment to up to 10 years post-treatment
The Esophageal Hypervigilance and Anxiety Scale (EHAS) is utilized to assess esophageal-specific hypervigilance and anxiety. It comprises two subscales with a total score ranging from 0 to 56, with higher scores indicating more severe esophageal hypervigilance and anxiety.
Time frame: From pre-treatment to up to 10 years post-treatment
The Hospital Anxiety and Depression Scale (HADS) is employed to evaluate patient anxiety and depression. It comprises two subscales with a total score ranging from 0 to 42, with higher scores indicating more severe states of anxiety and depression.
Time frame: From pre-treatment to up to 10 years post-treatment
Evaluated via gastroscopy according to the Los Angeles (LA) classification.
Time frame: From pre-treatment to up to 10 years post-treatment
Evaluated via gastroscopy according to the Hill classification.
Time frame: From pre-treatment to up to 10 years post-treatment
Evaluated via gastroscopy.
Time frame: From pre-treatment to up to 10 years post-treatment
Quantified via pH-impedance monitoring. AET serves as the primary and most reliable metric for diagnosing objective GERD and evaluating the true burden of acid reflux, >4% indicate abnormal acid reflux
Time frame: From pre-treatment to up to 10 years post-treatment
Quantified via pH-impedance monitoring.
Time frame: From pre-treatment to up to 10 years post-treatment
The DeMeester Composite Score quantifies the severity of Gastroesophageal Reflux Disease (GERD). It is calculated from 24-hour ambulatory esophageal pH monitoring using six acid exposure parameters: percentage of total, upright, and supine time with pH < 4; total reflux episodes; episodes lasting > 5 minutes; and the duration of the longest episode. Each parameter is scored using the formula SV = (X - A) / SD + 1, where X is the measured value, A is the healthy baseline mean, and SD is the baseline standard deviation. The total score is the sum of these six values. Minimum value: 0. Maximum value: No fixed upper limit (unbounded). In clinical applications, higher scores indicate more severe pathological acid exposure.
Time frame: From pre-treatment to up to 10 years post-treatment
Derived from pH-impedance monitoring to determine the temporal correlation between symptom events and reflux episodes, confirming whether a patient's symptoms are specifically reflux-driven. An SI of ≥ 50% is universally considered positive, indicating a clinically meaningful symptom-reflux association.
Time frame: From pre-treatment to up to 10 years post-treatment
Derived from pH-impedance monitoring to provide statistical validation of the symptom-reflux association, which is crucial for accurately phenotyping functional versus organic GERD. An SRI of ≥ 95% (often utilized interchangeably with Symptom Association Probability, SAP) is considered positive, providing strong statistical evidence that symptoms are not occurring by chance.
Time frame: From pre-treatment to up to 10 years post-treatment
Measured via high-resolution manometry (HRM).
Time frame: From pre-treatment to up to 10 years post-treatment
Measured via high-resolution manometry (HRM).
Time frame: From pre-treatment to up to 10 years post-treatment
Evaluated via high-resolution manometry (HRM) to assess hiatal hernia status.
Time frame: From pre-treatment to up to 10 years post-treatment
Measured via high-resolution manometry (HRM).
Time frame: From pre-treatment to up to 10 years post-treatment
Measured via high-resolution manometry (HRM).
Time frame: From pre-treatment to up to 10 years post-treatment
Evaluated via high-resolution manometry (HRM) according to the Chicago classification.
Time frame: From pre-treatment to up to 10 years post-treatment
Evaluated via computed tomography (CT).
Time frame: From 30 days prior to surgery to 10 years post-surgery
Helicobacter pylori infection status determined by ¹³C/¹⁴C urea breath test.
Time frame: From enrollment to the end of treatment, assessed up to 12 weeks
This encompasses the specific medication name, prescribed dosage, and administration frequency.
Time frame: At the time of surgery
Time frame: At the time of surgery
Time frame: From treatment to 30 days after surgery
Time frame: From treatment to 30 days after surgery
Time frame: From treatment to 30 days after surgery
Contact information is provided by the study sponsor or research team.
Beijing Friendship Hospital
Other
Establishing an Innovative Cohort of Chinese Patients With Gastroesophageal Reflux Disease Based on the Prospective Database of the National Clinical Research Center for Digestive Diseases: A Retrospective Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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